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Accessible Hearing Care Interventions for Hearing Loss
N/A
Recruiting
Led By Marcia J Hay-McCutcheon, PhD
Research Sponsored by University of Alabama, Tuscaloosa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
40 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a baseline outcome will be obtained prior to over-the-counter hearing aid fitting. outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Awards & highlights
Study Summary
This trial will study how well three different interventions work to improve quality of care for adults with mild-to-moderate hearing loss who don't have access to hearing healthcare.
Who is the study for?
This trial is for adults over 40 living in West Central or South Alabama who have mild-to-moderate hearing loss. It's not open to those with severe cognitive impairments from conditions like stroke, head injury, dementia, or Alzheimer's disease.Check my eligibility
What is being tested?
The study tests three interventions: providing personal sound amplification products (PSAPs), a four-week aural rehabilitation program, and PSAP fitting/orientation alongside regular hearing evaluations to improve hearing healthcare access and affordability.See study design
What are the potential side effects?
There are generally no significant side effects expected from the interventions being tested as they involve non-invasive measures such as using PSAPs and participating in rehabilitation programs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a baseline outcome will be obtained prior to over-the-counter hearing aid fitting. outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a baseline outcome will be obtained prior to over-the-counter hearing aid fitting. outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes
Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes
Secondary outcome measures
Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes
Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes
Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)Experimental Treatment3 Interventions
This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.
Group II: Over-the-Counter Only (OTC-Only)Active Control2 Interventions
This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.
Group III: Audiology Best Practices (ABP)Active Control2 Interventions
This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamOTHER
1,588 Previous Clinical Trials
2,280,102 Total Patients Enrolled
University of Alabama, TuscaloosaLead Sponsor
44 Previous Clinical Trials
19,306 Total Patients Enrolled
Marcia J Hay-McCutcheon, PhDPrincipal InvestigatorThe University of Alabama, Tuscaloosa
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe cognitive issues from conditions like stroke or Alzheimer's.I am 40 years old or older.I have some difficulty hearing.You live in West Central or South Alabama.
Research Study Groups:
This trial has the following groups:- Group 1: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)
- Group 2: Over-the-Counter Only (OTC-Only)
- Group 3: Audiology Best Practices (ABP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives has this research endeavor set out to accomplish?
"This study's primary goal is to assess the efficacy of over-the-counter hearing aids using International Outcome Inventory for Hearing Aids (IOI-HA) metrics. Secondary objectives focus on measuring changes in Client Oriented Scale of Improvement (COSI), Northwestern University-6 (NU-6) Word Recognition, and Quick Speech In Noise (SIN) Word Recognition outcomes across baseline measurements at 4 weeks into treatment, 14 weeks into treatment, and finally 1 year after completion."
Answered by AI
Are there still opportunities for enrollment in this clinical trial?
"According to the data found on clinicaltrials.gov, this research endeavour is actively enrolling candidates for participation. The initial posting date was January 1st 2021 and a recent update was made September 29th 2022."
Answered by AI
What is the quota for participants in this experimental research?
"Affirmative. Records available on clinicaltrials.gov demonstrate that this medical study, first posted on January 1st 2021, is still open for recruitment and requires 210 patients to be enrolled in a single site."
Answered by AI
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